Mental Health Clinical Trials Market Size & Share Analysis - Growth, Trends and Forecasts (2024 - 2029)

Mental Health Clinical Trials Market Size & Share Analysis - Growth, Trends and Forecasts (2024 - 2029)

The Mental Health Clinical Trials Market size is estimated at USD 3.20 billion in 2024, and is expected to reach USD 4.77 billion by 2029, growing at a CAGR of 8% during the forecast period (2024-2029).

The key factors driving the growth of the mental health clinical trials market are the increasing prevalence of mental health disorders, increased funding from government agencies, pharmaceuticals, and biotech companies, rising number of clinical trials, and growing awareness of mental health conditions.

The increasing prevalence of mental health conditions such as anxiety disorders, depression, and bipolar affective disorder drives the growth of the mental health clinical trials market. For instance, according to research published by the WHO in March 2023, it was anticipated that 280 million people globally suffer from depression. Females are more inclined than males to suffer from depression by roughly 50%. More than 10% of pregnant women and new mothers experience depression. It is estimated that 5% of adults suffer from depression globally. As mentioned above, the growing mental health conditions and the need for advanced therapies are fueling the market's growth and the demand for clinical trials in mental health.

Also, the growing awareness of mental health conditions drives the demand for mental health clinical trials market. For the past 20 years, the Substance Abuse and Mental Health Services Administration (SAMHSA) has recognized Mental Health Awareness Month (MHAM) every May to raise public awareness of the essential function that mental health plays in overall well-being and health in the United States. In February 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced USD 36.9 million in notices of funding opportunities for grant programs supporting behavioral health services across the country. Furthermore, in 2022, SAMHSA-funded mental health initiatives such as Project Advancing Wellness and Resiliency in Education received USD 73.6 million for the development of school-based mental health services and activities, USD 57.7 million for Mental Health Awareness Training, and USD 19.5 million for the National Child Traumatic Stress Initiative. These initiatives would further increase the research and development of mental health and further strengthen the demand for mental health clinical trials.

Moreover, the major factors contributing to the market growth are the rising technological advancements such as remote monitoring, wearable devices, digital data collection, e-consent, and virtual reality and augmented reality for cognitive training in mental health. For instance, in May 2024, Oxehealth announced FDA and EU clearances of new sleep monitoring software, extending the scope of its contactless patient monitoring platform. It assesses patients' sleep/wake patterns with a level of accuracy that is comparable to polysomnography and provides automated daily outputs that healthcare staff can use to support clinical decision-making. Such launches increase research and development, boosting the clinical trials in the market. Thus, the adoption of the technologies drives the growth of the mental health clinical trials market.

However, the stringent regulations related to mental health clinical trials, retirement difficulties, and high dropouts are likely to hinder market growth over the forecast period.

Mental Health Clinical Trials Market Trends

Phase III Clinical Trials is Expected to Hold Significant Share in the Market During the Forecast Period

Phase III clinical trial is expected to have a significant impact over the period as it involves investigating a drug's efficacy, safety, and side effects on a large patient population across numerous facilities. The increase in the burden of diseases and rising research activities drive segment growth during the forecast period. For instance, in January 2023, phase III research findings for the oral antipsychotic iloperidone, used to treat bipolar I disorder, were released by Vanda Pharmaceuticals. The results were developed from a placebo-controlled experiment involving 400 individuals with bipolar I disorder with current manic episodes. Iloperidone is approved in the United States under the brand name Fanapt for the treatment of schizophrenia. In 2023, Vanda intended to file a supplemental new drug application to treat bipolar I patients suffering from acute manic and mixed episodes. Such a positive development in phase III trials depicts the growth of the segment.

The high number of mental health clinical trials in phase III is driving the growth of the market segment. For instance, an article published by Springer Nature Limited in May 2023 reported that 552 patients participated in the phase III multicenter, double-blind, randomized, placebo-controlled clinical trial to verify the efficacy of ansofaxine (LY03005) for the treatment of major depressive illness. Also, the phase III EMERGENT-2 trial for KarXT as a schizophrenia treatment by Karuna Therapeutics reported promising results in August 2022. According to a late-stage readout from the EMERGENT-3 trial, an 8.4-point larger reduction on the positive and negative syndrome scale was seen in persons with schizophrenia receiving KarXT compared to a placebo in March 2023. These promising results are expected to increase the segment's growth in the market studied.

Thus, the factors mentioned above are expected to propel the segment's growth over the forecast period.

North America Holds the Largest Market Share of the Mental Health Clinical Trials Market

North America is expected to dominate the mental health clinical trials market over the forecast period owing to the rising prevalence of mental health disorders such as anxiety, depression, and substance use, advancement in technologies, and favorable regulatory environment. For instance, according to a report published by Mental Health America in 2023, 21% of adults had a mental illness in approximately 50 million people in the United States, and around 15% of adults had a substance use disorder in 2022. The top-ranking states in the United States for the prevalence of mental illness among adults, serious depression, and people not receiving any mental health services are Arizona, Kansas, West Virginia, Texas, and Indiana. Thus, the growing number of mental health disorders in the country is expected to drive the growth of mental health clinical trials in the region.

Rising investments by companies, universities, and government institutions increase the demand for mental health workers and assess the need for medical treatment disorders in different states of the United States. For instance, in June 2023, the Indiana University School of Medicine collaborated with Lilly Endowment Inc. and received a grant of USD 515,005. This collaborative initiative with partners across Indiana is designed to gain insight into Indiana's post-secondary pipeline of mental and behavioral health care providers. The primary objective of the project is to comprehend the post-secondary pipeline for those training in particular professional fields in the area of behavioral and mental health care. Thus, investment and collaborations with government institutions and companies would increase the demand for healthcare workers, further contributing to the growth of the mental health clinical trials market.

In addition, the strong presence of large biopharmaceutical and pharmaceutical players such as Eli Lilly, Johnson & Johnson, and Pfizer contributes to the market growth. Key market players are undertaking various strategic initiatives such as partnerships, mergers and acquisitions, collaborations, and geographic expansions, to strengthen their services, thus providing a competitive advantage. For instance, in April 2023, CHEPLAPHARM acquired Zyprexa, an antipsychotic drug of Eli Lily and Company. This product is indicated for the treatment of schizophrenia and bipolar disorders.

In addition, there were numerous trials on drug development for serious mental illness in the United States. For instance, pharmaceutical firms initiate and fund most clinical research in the United States, according to a report released by the Center for the Evaluation of Value and Risk in Health. The pharmaceutical industry funded 239 clinical trials for novel drugs to treat serious mental disorders between the period of 2015 and 2022. Thus, the rising number of clinical trials and the contribution of the biopharma and pharma companies would further strengthen the mental health clinical trials market in the country. Therefore, due to the factors mentioned above, the mental health clinical trials market is expected to expand in the region over the forecast period.

Mental Health Clinical Trials Industry Overview

The mental health clinical trials market is highly competitive. The key market players include IQVIA, LabCorp Drug Development, Parexel International Corporation, and Pharmaceutical Product Development, LLC. Major players also adopt various strategies, including mergers and acquisitions and partnerships, to maintain market share and expand their product and service offerings.

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